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Pharmaceutical
India’s Sun Pharmaceutical Industries has presented Phase IV data on its Cequa (cyclosporine ophthalmic solution) showing sustained improvement in dry eye disease signs and symptoms in patients switched from AbbVie’s Restasis (cyclosporine ophthalmic emulsion) 0.05%. 12 October 2023
Biosimilars
South Korea’s Samsung Bioepis today released the Fourth Quarter 2023 Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the USA. 10 October 2023
Pharmaceutical
French pharma major Sanofi is exploring a potential acquisition of cancer drugmaker Mirati Therapeutics, according to Bloomberg, citing people familiar with the matter, and other media reports. 6 October 2023
Biotechnology
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on Swedish biotech Calliditas’ application for orphan drug designation in the European Union for setanaxib in Alport syndrome. 5 October 2023
Biosimilars
US pharma giant Pfizer today announced that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to AbbVie’s mega-blockbuster Humira (adalimumab). 5 October 2023
Pharmaceutical
Japan’s largest drugmaker Takeda revealed that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization has recommended the use of its Qdenga (dengue tetravalent vaccine [live, attenuated]; TAK-003). 5 October 2023
Pharmaceutical
Novo Nordisk’s American traded shares rose 1% after the Danish diabetes care giant won two patent challenges related to semaglutide, its best-selling weight-loss therapy, Wegovy, also marketed as Ozempic for diabetes. 3 October 2023
Biotechnology
UK-based Mogrify has announced an additional $10 million closing of its Series A financing, bringing the total raised in the round to $46 million. 2 October 2023
Biotechnology
Chugai Pharmaceutical says that it launched Enspryng (satralizumab) in Taiwan on October 1 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult and adolescent over 12 years old patients who are anti-aquaporin-4 (AQP4) antibody positive” as the first indication in Taiwan. 2 October 2023
Pharmaceutical
With the threat of a federal government shutdown looming in America, the operations of the US Food and Drug Administration (FDA) may be impacted creating some potential application delays for pharmaceutical and medical device companies. 30 September 2023
Pharmaceutical
The US Food and Drug Administration announced it has awarded 10 new clinical trial studies, funded by Congress through the Orphan Products Grants Program, to support the development of medical products for rare diseases. 30 September 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Tetra Therapeutics, now a part of Japanese drugmaker Shionogi, Rare Pediatric Disease designation for zatolmilast (BPN14770). 29 September 2023
Pharmaceutical
A number of drugmakers are preparing to engage with administrators at Medicare to negotiate certain drug prices, as mandated by the Inflation Reduction Act (IRA), according to a report. 28 September 2023
Biotechnology
Dutch rare diseases biotech ProQR Therapeutics today disclosed that its previously announced accord to divest the company’s late-stage ophthalmic assets to France-based Laboratoires Théa has been terminated. 27 September 2023
Biotechnology
A-Alpha Bio (A-Alpha), a US synthetic biology and machine learning company that measures and engineers protein-protein interactions, today announced the expansion of its collaboration with US biotech giant Amgen's Induced Proximity Platform to characterize interactions between ligases and molecular glue targets for protein degradation. 26 September 2023
Biotechnology
Japanese drugmaker Eisai and US partner Biogen today announced that their humanized amyloid-beta (Aβ) monoclonal antibody Leqembi Intravenous Infusion (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). 25 September 2023
Pharmaceutical
The first Rare Disease Research Landscape report has been published by the UK’s National Institute of Health Research (NIHR) in collaboration with the Medical Research Council (MRC), industry, charities and the devolved administrations. 23 September 2023
Biotechnology
A new center to develop cutting-edge vaccines and therapeutics is set to open today in Darlington, UK. 21 September 2023
Pharmaceutical
Indian oncology company Venus Remedies has secured marketing authorization from Serbia for its chemotherapy drugs gemcitabine and docetaxel. 20 September 2023
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Biotechnology
The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM; USA, France, Germany, Italy, Spain, UK and Japan). 20 November 2024
Biotechnology
Johnson & Johnson and partner Protagonist Therapeutics have reported positive topline results from two Phase III studies testing a first-in-class oral peptide. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
Samsung Biologics, the biotech arm of Korea's Samsung Group, has announced a new manufacturing agreement worth $668 million. 20 November 2024
Biotechnology
Mirai Bio has announced the appointment of Jens Vogel as the company’s president and chief operating officer (COO). 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
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